Liquid composition containing taxane-based active ingredient, process for producing same, and liquid preparation

Abstract

A liquid composition which includes a taxane-based active ingredient (a) selected from the group consisting of docetaxel and a derivative thereof; at least one glycol (b); and at least one surfactant component (c) selected from the group consisting of a polysorbate, a polyoxyethylene glycol ester, and a polyoxyethylene castor oil derivative, in which a volume ratio of the glycol (b) to the surfactant component (c) is in a range of form 45/55 to 55/45, and a total content of the glycol (b) and the surfactant component (c) with respect to a total volume of the liquid composition is 95% (v/v) or more.

The invention claimed is: 
     
       1. A liquid composition, comprising:
 at least one taxane-based active ingredient selected from the group consisting of docetaxel and a docetaxel trihydrate; 
 polyethyelene glycol 300; 
 polysorbate 80; and 
 anhydrous citric acid at a concentration of from 1.0 mg/mL to 4.0 mg/mL, 
 wherein a volume ratio of the polyethyelene glycol 300 to the polysorbate 80 is in a range of from 47.5/52.5 to 52.5/47.5, and 
 a total content of the polyethyelene glycol 300 and the polysorbate 80 with respect to a total volume of the liquid composition is 95% (v/v) or more. 
 
     
     
       2. The liquid composition according to  claim 1 , wherein a concentration of the taxane-based active ingredient is from 16 mg/mL to 24 mg/mL. 
     
     
       3. The liquid composition according to  claim 1 , wherein the polysorbate 80 has a peroxide value of 5 meq/kg or less. 
     
     
       4. The liquid composition according to  claim 1 , which has a pH within a range of from 3.0 to 4.5 when diluted fivefold with distilled water. 
     
     
       5. The liquid composition according to  claim 1 , wherein a content of ethanol with respect to a total volume of the liquid composition is less than 1% (v/v). 
     
     
       6. A liquid preparation comprising the liquid composition according to  claim 1  contained in a vial container, an amount of sodium that leaches from the vial container into water being 1 ppm or less when the vial container has been charged with water and heated at 121° C. for 60 minutes.